65669 Federal Register T 4—E

Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
65669
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden
per recordkeeping
Total hours
312.57, Sponsor recordkeeping showing
the receipt, shipment, or other disposition of the investigational drug, and
any financial interests.
312.62(a), Investigator recordkeeping of
the disposition of drugs.
312.62(b), Investigator recordkeeping of
case histories of individuals.
312.160(a)(3), Records pertaining to the
shipment of drugs for investigational
use in laboratory research animals or
in vitro tests.
312.160(c), Shipper records of alternative disposition of unused drugs.
335
2.70
904
100 ...................
90,400
453
1
453
40 .....................
18,120
453
1
453
40 .....................
18,120
111
1.40
155
0.50 (30 minutes).
78
111
1.40
155
0.50 (30 minutes).
78
Total .................................................
..............................
................................
..............................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA or we) is
correcting a notice that appeared in the
Federal Register of August 14, 2014.
The notice announced that a proposed
collection of information had been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
Reduction Act of 1995. In this
document, we correct some errors that
appeared in the notice.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, [email protected]
fda.hhs.gov.
SUMMARY:
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In FR Doc.
2014–19241, appearing on page 47642
in the Federal Register of August 14,
2014 (79 FR 47642), we make the
following corrections:
1. On page 47643, in the second
column, in the Response to Comment 3,
delete the sentence starting with ‘‘The
scope of the voluntary submission . . .
and the product label.’’
2. On page 47643, in the second
column, in the Response to Comment 3,
in the sentence starting with
‘‘Consequently, we have proposed
. . .,’’ delete ‘‘institute the voluntary
consultation process discussed in this
document’’ and replace it with ‘‘provide
for the voluntary registration and Form
FDA 2541e submission process’’.
3. On page 47643, in the second and
third columns, in the Response to
Comment 3, delete the sentences
starting with ‘‘The ability to submit a
voluntary submission . . . of part 114’’
and the remaining sentences in the
response and replace them with ‘‘FDA
has authority to implement the
voluntary submission process under
sections 402 and 404 of the FD&C Act.’’
4. On page 47643, in the third
column, in the Response to Comment 4,
replace the response with the following:
‘‘A voluntary process filing submission
will not result in part 114 applying to
products that are not acidified foods as
defined in 21 CFR 114.3(b). Further, the
voluntary process filing submission
process will not result in any changes to
part 114.’’
5. On pages 47643 to 47644, in the
third column on page 47643 and in the
first column on page 47644, in the
Response to Comment 5, replace the
response with the following: ‘‘Our
inspectors will not expect all
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–26304 Filed 11–4–14; 8:45 am]
AGENCY:
...........................
127,006
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
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Number of records
per recordkeeper
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manufacturers to submit voluntary
submissions.’’
6. On page 47644, in the first column,
in the Response to Comment 7, replace
the response with the following: ‘‘As
discussed in the response to Comment
4, if a product is not an acidified food,
the product is not subject to the good
manufacturing practice requirements in
part 114 and will not become subject to
those regulations as a result of a
voluntary submission.’’
7. On page 47644, in the first and
second columns, in the Response to
Comment 8, replace the response with
the following: ‘‘The draft guidance did
address the issue of what constitutes a
fermented food. We expect that the
acidified foods guidance, when
finalized, will provide guidance on
what constitutes a fermented food.’’
8. On page 47644, in the second
column, in the Response to Comment 9,
replace the response with the following:
‘‘Manufacturers are free to decide
whether to make a voluntary
submission, and we believe that some
manufacturers may choose to do so. For
FDA, the voluntary submission results
in increased efficiency.’’
9. On page 47644, in the second and
third columns, in the Response to
Comment 10, delete the first paragraph
of the response and delete the second
sentence in the second paragraph of the
response.
10. On page 47645, in the first
column, in the Response to Comment
13, in the second sentence in the second
paragraph of the response, delete ‘‘to
prevent the detention of product’’.
11. On page 47645, in the third
column, in the Response to Comment
20, in the first sentence of the response,
replace ‘‘and provides’’ with ‘‘and,
when finalized, will provide’’.
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65670
Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
12. On page 47646, in the first
column, in the Response to Comment
21, in the first sentence of the response,
delete ‘‘from the coverage of part 114’’
and, at the end of the first sentence of
the response, insert ‘‘or that do not
otherwise meet the definitions of
acidified food.’’
13. On page 47646, in the first
column, in the Response to Comment
22, replace the response with the
following: ‘‘FDA does not agree that the
‘Food Product Group’ categories in any
way indicates FDA’s thinking as to
whether all fruit and vegetable juices are
acidified foods and are therefore subject
to the acidified foods regulations in
parts 108 and 114. Rather, the ‘Food
Product Group’ categories are designed
to help FDA understand the nature of
products. For more information on what
constitutes an acidified food, we
recommend manufacturers consult the
definition of acidified foods in
§ 114.3(b).’’
14. On page 47646, in the second
column, in the Response to Comment
24, replace the second paragraph of the
response with the following: ‘‘When
optional information about the ‘Food
Product Group’ category is provided, we
will use it to help us understand the
nature of the products and to help us
prioritize which facilities to inspect.’’
Dated: October 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26238 Filed 11–4–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 11, 2014, from 8 a.m.
to 3:30 p.m.
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Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: http://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
[email protected], or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at http://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: Information will be
presented to gauge investigator interest
in exploring potential pediatric
development plans for three products in
various stages of development for adult
cancer indications. The subcommittee
will consider and discuss issues
concerning diseases to be studied,
patient populations to be included, and
possible study designs in the
development of these products for
pediatric use. The discussion will also
provide information to the Agency
pertinent to the formulation of written
requests for pediatric studies, if
appropriate. The products under
consideration are: (1) GANETESPIB,
application submitted by Synta
Pharmaceuticals Corp. (2) Etirinotecan,
application submitted by Nektar
Therapeutics, and (3) RO5503781,
application submitted by Hoffmann-La
Roche, Inc.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
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meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at http://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before December 3, 2014.
Oral presentations from the public will
be scheduled between approximately
8:55 a.m. to 9:15 a.m., 11:10 a.m. to
11:30 a.m., and 2:10 p.m. to 2:30 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before November 25, 2014. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 26, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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